Preferred Label : Reviewable Unit;
NCIt related terms : ReviewableUnit;
NCIt definition : A predefined portion of an application that, by agreement between the applicant and
the review division, can be submitted prior to submission of a complete application.;
Alternative definition : BRIDG 3.0.3: A discrete portion of a submission which is used to receive agreement.
Once agreement is reached on all units within the submission the submission can then
be approved. EXAMPLE(S): In a Modular pre-marketing application (PMA) several modules
will be sent to the Food & Drug Administration (FDA). Each module will be agreed upon
independently of other modules. The FDA then approves the submission based on compilation
of all of the modules. These modules are reviewable units. A veterinary medicine New
Animal Drug Application (NADA) (marketing application) is constructed from the Investigational
New Animal Drug Application (INADA). In the INADA process the sponsor creates reviewable
units. These reviewable units are then compiled to be used as documentation for the
marketing application.; BRIDG 5.3: A discrete portion of a submission which is used to receive agreement.
Once agreement is reached on all units within the submission the submission can then
be approved. EXAMPLE(S): In a Modular pre-marketing application (PMA) several modules
will be sent to the Food and Drug Administration (FDA). Each module will be agreed
upon independently of other modules. The FDA then approves the submission based on
compilation of all of the modules. These modules are reviewable units. A veterinary
medicine New Animal Drug Application (NADA) (marketing application) is constructed
from the Investigational New Animal Drug Application (INADA). In the INADA process
the sponsor creates reviewable units. These reviewable units are then compiled to
be used as documentation for the marketing application. OTHER NAME(S): NOTE(S):;
Origin ID : C70721;
UMLS CUI : C2347962;
Semantic type(s)
- concept_is_in_subset
